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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Primary Purpose

AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Freezor Xtra Cryoablation Catheter
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AtrioVentricular Nodal Reentrant Tachycardia focused on measuring Cardiac cryoablation, AVNRT, heart disease, tachycardia, AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular tachycardia, SVT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Pre-Electrophysiology Study Inclusion Criteria:

  • Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Pre-Electrophysiology Study Exclusion Criteria:

  • History of sustained (≥30 seconds) of ventricular tachycardia
  • Atrial tachycardia or other arrhythmia that could be confused with AVNRT
  • Reversible cause of SVT
  • History of previous AVNRT ablation
  • Therapy with amiodarone within last 90 days
  • Unstable angina/myocardial infarction/open heart surgery in past 60 days
  • New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
  • Implantable cardiac rhythm device
  • Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
  • Stroke or transient ischemic attack within the past 180 days
  • Life expectancy less than 12 months
  • Female known to be pregnant
  • Unable/unwilling to give informed consent
  • Unable/unwilling to comply with follow-up visits and study requirements
  • Less than 18 years of age
  • Active systemic infection
  • Cryoglobulinemia
  • Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
  • Participating in a concurrent clinical study that may confound the results of this study

Post-Electrophysiology Study Inclusion Criteria:

  • Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

  • Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
  • Presence of inducible sustained ventricular tachycardia or fibrillation
  • Presence of an accessory pathway
  • Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
  • Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)

Sites / Locations

  • Banner Good Samaritan Medical Center
  • Pacific Heart Institute
  • Stanford Hospital and Clinics
  • Baptist Hospital of Miami
  • Orlando Regional Medical Center
  • Piedmont Heart Institute
  • Advocate Christ Medical Center
  • Iowa Heart Center
  • University of Michigan Medical Center
  • Park Nicollet Institute
  • Healtheast St. Joseph's Hospital
  • Southside Hospital
  • Montefiore Medical Center
  • University of Rochester Medical Center
  • Sanger Heart and Vascular Institute
  • Cleveland Clinic
  • Miami Valley Cardiologists
  • Sacred Heart Medical Center
  • Capital Cardiovascular Associates
  • Geisinger Medical Center
  • Geisinger Wyoming Valley Medical Center
  • Wellmont Cardiovascular Heart Institute
  • Baylor Heart and Vascular Hospital
  • St. Luke's Episcopal
  • Baylor Research Institute
  • Virginia Heart
  • Royal Alexandra Hospital
  • Victoria Cardiac Arrhythmia Trials, Inc.
  • London Health Sciences Centre
  • Montreal Heart Institute
  • Hopital du Sacre Coeur de Montreal
  • McGill University Health Centre
  • Centre Hospitalier Universitaire de Sherbrooke
  • Prairie CardioVascular Research Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation

Arm Description

Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.

Outcomes

Primary Outcome Measures

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.

Secondary Outcome Measures

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.
If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

Full Information

First Posted
August 29, 2011
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01426425
Brief Title
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Official Title
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
Keywords
Cardiac cryoablation, AVNRT, heart disease, tachycardia, AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular tachycardia, SVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Intervention Type
Device
Intervention Name(s)
Freezor Xtra Cryoablation Catheter
Intervention Description
Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.
Primary Outcome Measure Information:
Title
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Description
Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.
Time Frame
6 months
Title
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
Description
Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.
Description
If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Pre-Electrophysiology Study Inclusion Criteria: Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor Pre-Electrophysiology Study Exclusion Criteria: History of sustained (≥30 seconds) of ventricular tachycardia Atrial tachycardia or other arrhythmia that could be confused with AVNRT Reversible cause of SVT History of previous AVNRT ablation Therapy with amiodarone within last 90 days Unstable angina/myocardial infarction/open heart surgery in past 60 days New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days Implantable cardiac rhythm device Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block Stroke or transient ischemic attack within the past 180 days Life expectancy less than 12 months Female known to be pregnant Unable/unwilling to give informed consent Unable/unwilling to comply with follow-up visits and study requirements Less than 18 years of age Active systemic infection Cryoglobulinemia Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus) Participating in a concurrent clinical study that may confound the results of this study Post-Electrophysiology Study Inclusion Criteria: Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT. Post-Electrophysiology Study Exclusion Criteria: Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months Presence of inducible sustained ventricular tachycardia or fibrillation Presence of an accessory pathway Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system. Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wells, M.D.
Organizational Affiliation
Baylor Univ Medical Ctr Dallas, TX.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Park Nicollet Institute
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Healtheast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Southside Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Miami Valley Cardiologists
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Sacred Heart Medical Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Capital Cardiovascular Associates
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Wellmont Cardiovascular Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
St. Luke's Episcopal
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Virginia Heart
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Victoria Cardiac Arrhythmia Trials, Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B9
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hopital du Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Prairie CardioVascular Research Network
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P OW5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29044787
Citation
Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.
Results Reference
derived

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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

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